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Medscape Alerts
FDA Warning: DEG-Contaminated Glycerin Remains Potential
Health Hazard
Yael Waknine
May
8, 2007 — Healthcare professionals and others who compound
medications using glycerin are being reminded of the importance
of testing for diethylene glycol (DEG) contamination before use,
the US Food and Drug Administration (FDA) warned yesterday. DEG,
a solvent, is a known poison used in antifreeze.
Although the US supply of glycerin is not known to contain DEG,
contaminated glycerin is known to have caused deaths in other
countries over the past several years, according to an alert
sent yesterday from MedWatch, the FDA's safety information and
adverse-event reporting program.
The
most recent incident was reported in Panama in September 2006;
dozens of hospitalizations and more than 40 deaths were
attributed to DEG-contaminated glycerin used to sweeten cough
syrup. In late 1995 and early 1996, at least 80 pediatric deaths
in Haiti were linked to DEG-contaminated glycerin in
acetaminophen syrup. Similar incidents reported between 1990 and
1998 led to hundreds of deaths in Argentina, Bangladesh, India,
and Nigeria.
The
FDA notes that the Federal Food, Drug, and Cosmetic Act to
regulate drug safety was enacted after more than 100 US deaths
in 1937 were linked to the use of DEG-contaminated sulfanilamide
elixir.
Because of the serious and potentially fatal nature of
DEG-related adverse events, an FDA guidance document has been
issued to the pharmaceutical industry regarding recommended
methods of testing glycerin and other controls to identify
potential contamination and prevent poisoning. The document is
available online at
http://www.fda.gov/cder/guidance/7654fnl.htm.
Healthcare professionals are encouraged to report adverse events
potentially related to DEG-contaminated glycerin-containing
products to the FDA's MedWatch reporting program by phone at
1-800-FDA-1088, by fax at 1-800-FDA-0178, online at
http://www.fda.gov/medwatch, or by mail to 5600 Fishers
Lane, Rockville, MD 20852-9787. Yael Waknine is a freelance writer for Medscape.
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